Cargando…
The impact of the COVID-19 pandemic on an international rehabilitation study in MS: the CogEx experience
Pandemic restrictions have led to changes in therapy plans and disrupted rehabilitation services for people with multiple sclerosis. CogEx is an international, multicentre MS dual-intervention (cognitive rehabilitation, aerobic exercise) randomized, controlled rehabilitation trial confined to people...
Autores principales: | , , , , , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Berlin Heidelberg
2021
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8570234/ https://www.ncbi.nlm.nih.gov/pubmed/34741240 http://dx.doi.org/10.1007/s00415-021-10881-3 |
_version_ | 1784594801059954688 |
---|---|
author | Feinstein, Anthony Amato, Maria Pia Brichetto, Giampaolo Chataway, Jeremy Chiaravalloti, Nancy D. Cutter, Gary Dalgas, Ulrik DeLuca, John Farrell, Rachel Feys, Peter Filippi, Massimo Freeman, Jennifer Inglese, Matilde Meza, Cecilia Motl, Rob Rocca, Maria Assunta Sandroff, Brian M. Salter, Amber |
author_facet | Feinstein, Anthony Amato, Maria Pia Brichetto, Giampaolo Chataway, Jeremy Chiaravalloti, Nancy D. Cutter, Gary Dalgas, Ulrik DeLuca, John Farrell, Rachel Feys, Peter Filippi, Massimo Freeman, Jennifer Inglese, Matilde Meza, Cecilia Motl, Rob Rocca, Maria Assunta Sandroff, Brian M. Salter, Amber |
author_sort | Feinstein, Anthony |
collection | PubMed |
description | Pandemic restrictions have led to changes in therapy plans and disrupted rehabilitation services for people with multiple sclerosis. CogEx is an international, multicentre MS dual-intervention (cognitive rehabilitation, aerobic exercise) randomized, controlled rehabilitation trial confined to people with progressive disease. The primary outcome is cognition (processing speed).There are 11 treatment sites in six countries with participants required to make 27 site visits over 12 weeks. Collectively, the large, in-person demands of the trial, and the varying international policies for the containment of COVID-19, might disproportionately impact the administration of CogEx. During the first lockdown, all centres closed on average for 82.9 (SD = 24.3) days. One site was required to lockdown on two further occasions. One site remained closed for 16 months. Ten staff (19.2%) were required to quarantine and eight staff (15.4%) tested positive for COVID. 10 of 264 (3.8%) participants acquired COVID-19. All survived. The mean duration of enrollment delay has been [236.7 (SD = 214.5) days]. Restarting participants whose interventions were interrupted by the pandemic meant recalculating the intervention prescriptions for these individuals. While the impact of the pandemic on CogEx has been considerable, all study sites are again open. Participants and staff have shown considerable flexibility and resilience in keeping a complex, international endeavour running. The future in general remains uncertain in the midst of a pandemic, but there is cautious optimism the study will be completed with sufficient sample size to robustly evaluate our hypothesis and provide meaningful results to the MS community on the impact of these interventions on people with progressive MS. Trial registration: The trial was registered on September 20th 2018 at www.clinicaltrials.gov having identifier NCT03679468. Registration was performed before recruitment was initiated. |
format | Online Article Text |
id | pubmed-8570234 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Springer Berlin Heidelberg |
record_format | MEDLINE/PubMed |
spelling | pubmed-85702342021-11-05 The impact of the COVID-19 pandemic on an international rehabilitation study in MS: the CogEx experience Feinstein, Anthony Amato, Maria Pia Brichetto, Giampaolo Chataway, Jeremy Chiaravalloti, Nancy D. Cutter, Gary Dalgas, Ulrik DeLuca, John Farrell, Rachel Feys, Peter Filippi, Massimo Freeman, Jennifer Inglese, Matilde Meza, Cecilia Motl, Rob Rocca, Maria Assunta Sandroff, Brian M. Salter, Amber J Neurol Original Communication Pandemic restrictions have led to changes in therapy plans and disrupted rehabilitation services for people with multiple sclerosis. CogEx is an international, multicentre MS dual-intervention (cognitive rehabilitation, aerobic exercise) randomized, controlled rehabilitation trial confined to people with progressive disease. The primary outcome is cognition (processing speed).There are 11 treatment sites in six countries with participants required to make 27 site visits over 12 weeks. Collectively, the large, in-person demands of the trial, and the varying international policies for the containment of COVID-19, might disproportionately impact the administration of CogEx. During the first lockdown, all centres closed on average for 82.9 (SD = 24.3) days. One site was required to lockdown on two further occasions. One site remained closed for 16 months. Ten staff (19.2%) were required to quarantine and eight staff (15.4%) tested positive for COVID. 10 of 264 (3.8%) participants acquired COVID-19. All survived. The mean duration of enrollment delay has been [236.7 (SD = 214.5) days]. Restarting participants whose interventions were interrupted by the pandemic meant recalculating the intervention prescriptions for these individuals. While the impact of the pandemic on CogEx has been considerable, all study sites are again open. Participants and staff have shown considerable flexibility and resilience in keeping a complex, international endeavour running. The future in general remains uncertain in the midst of a pandemic, but there is cautious optimism the study will be completed with sufficient sample size to robustly evaluate our hypothesis and provide meaningful results to the MS community on the impact of these interventions on people with progressive MS. Trial registration: The trial was registered on September 20th 2018 at www.clinicaltrials.gov having identifier NCT03679468. Registration was performed before recruitment was initiated. Springer Berlin Heidelberg 2021-11-05 2022 /pmc/articles/PMC8570234/ /pubmed/34741240 http://dx.doi.org/10.1007/s00415-021-10881-3 Text en © The Author(s), under exclusive licence to Springer-Verlag GmbH Germany 2021 This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic. |
spellingShingle | Original Communication Feinstein, Anthony Amato, Maria Pia Brichetto, Giampaolo Chataway, Jeremy Chiaravalloti, Nancy D. Cutter, Gary Dalgas, Ulrik DeLuca, John Farrell, Rachel Feys, Peter Filippi, Massimo Freeman, Jennifer Inglese, Matilde Meza, Cecilia Motl, Rob Rocca, Maria Assunta Sandroff, Brian M. Salter, Amber The impact of the COVID-19 pandemic on an international rehabilitation study in MS: the CogEx experience |
title | The impact of the COVID-19 pandemic on an international rehabilitation study in MS: the CogEx experience |
title_full | The impact of the COVID-19 pandemic on an international rehabilitation study in MS: the CogEx experience |
title_fullStr | The impact of the COVID-19 pandemic on an international rehabilitation study in MS: the CogEx experience |
title_full_unstemmed | The impact of the COVID-19 pandemic on an international rehabilitation study in MS: the CogEx experience |
title_short | The impact of the COVID-19 pandemic on an international rehabilitation study in MS: the CogEx experience |
title_sort | impact of the covid-19 pandemic on an international rehabilitation study in ms: the cogex experience |
topic | Original Communication |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8570234/ https://www.ncbi.nlm.nih.gov/pubmed/34741240 http://dx.doi.org/10.1007/s00415-021-10881-3 |
work_keys_str_mv | AT feinsteinanthony theimpactofthecovid19pandemiconaninternationalrehabilitationstudyinmsthecogexexperience AT amatomariapia theimpactofthecovid19pandemiconaninternationalrehabilitationstudyinmsthecogexexperience AT brichettogiampaolo theimpactofthecovid19pandemiconaninternationalrehabilitationstudyinmsthecogexexperience AT chatawayjeremy theimpactofthecovid19pandemiconaninternationalrehabilitationstudyinmsthecogexexperience AT chiaravallotinancyd theimpactofthecovid19pandemiconaninternationalrehabilitationstudyinmsthecogexexperience AT cuttergary theimpactofthecovid19pandemiconaninternationalrehabilitationstudyinmsthecogexexperience AT dalgasulrik theimpactofthecovid19pandemiconaninternationalrehabilitationstudyinmsthecogexexperience AT delucajohn theimpactofthecovid19pandemiconaninternationalrehabilitationstudyinmsthecogexexperience AT farrellrachel theimpactofthecovid19pandemiconaninternationalrehabilitationstudyinmsthecogexexperience AT feyspeter theimpactofthecovid19pandemiconaninternationalrehabilitationstudyinmsthecogexexperience AT filippimassimo theimpactofthecovid19pandemiconaninternationalrehabilitationstudyinmsthecogexexperience AT freemanjennifer theimpactofthecovid19pandemiconaninternationalrehabilitationstudyinmsthecogexexperience AT inglesematilde theimpactofthecovid19pandemiconaninternationalrehabilitationstudyinmsthecogexexperience AT mezacecilia theimpactofthecovid19pandemiconaninternationalrehabilitationstudyinmsthecogexexperience AT motlrob theimpactofthecovid19pandemiconaninternationalrehabilitationstudyinmsthecogexexperience AT roccamariaassunta theimpactofthecovid19pandemiconaninternationalrehabilitationstudyinmsthecogexexperience AT sandroffbrianm theimpactofthecovid19pandemiconaninternationalrehabilitationstudyinmsthecogexexperience AT salteramber theimpactofthecovid19pandemiconaninternationalrehabilitationstudyinmsthecogexexperience AT theimpactofthecovid19pandemiconaninternationalrehabilitationstudyinmsthecogexexperience AT feinsteinanthony impactofthecovid19pandemiconaninternationalrehabilitationstudyinmsthecogexexperience AT amatomariapia impactofthecovid19pandemiconaninternationalrehabilitationstudyinmsthecogexexperience AT brichettogiampaolo impactofthecovid19pandemiconaninternationalrehabilitationstudyinmsthecogexexperience AT chatawayjeremy impactofthecovid19pandemiconaninternationalrehabilitationstudyinmsthecogexexperience AT chiaravallotinancyd impactofthecovid19pandemiconaninternationalrehabilitationstudyinmsthecogexexperience AT cuttergary impactofthecovid19pandemiconaninternationalrehabilitationstudyinmsthecogexexperience AT dalgasulrik impactofthecovid19pandemiconaninternationalrehabilitationstudyinmsthecogexexperience AT delucajohn impactofthecovid19pandemiconaninternationalrehabilitationstudyinmsthecogexexperience AT farrellrachel impactofthecovid19pandemiconaninternationalrehabilitationstudyinmsthecogexexperience AT feyspeter impactofthecovid19pandemiconaninternationalrehabilitationstudyinmsthecogexexperience AT filippimassimo impactofthecovid19pandemiconaninternationalrehabilitationstudyinmsthecogexexperience AT freemanjennifer impactofthecovid19pandemiconaninternationalrehabilitationstudyinmsthecogexexperience AT inglesematilde impactofthecovid19pandemiconaninternationalrehabilitationstudyinmsthecogexexperience AT mezacecilia impactofthecovid19pandemiconaninternationalrehabilitationstudyinmsthecogexexperience AT motlrob impactofthecovid19pandemiconaninternationalrehabilitationstudyinmsthecogexexperience AT roccamariaassunta impactofthecovid19pandemiconaninternationalrehabilitationstudyinmsthecogexexperience AT sandroffbrianm impactofthecovid19pandemiconaninternationalrehabilitationstudyinmsthecogexexperience AT salteramber impactofthecovid19pandemiconaninternationalrehabilitationstudyinmsthecogexexperience AT impactofthecovid19pandemiconaninternationalrehabilitationstudyinmsthecogexexperience |